CAM 20146

Vacuum Therapy as a Treatment for Female Sexual Dysfunction

Category:Medicine   Last Reviewed:January 2019
Department(s):Medical Affairs   Next Review:January 2999
Original Date:November 2001    

Description:
Sexual dysfunction may be defined as the persistent impairment of a couple’s normal or usual patterns of sexual interest and/or responses. Female sexual dysfunction may be classified into one or more of the following categories:

  1. Sexual desire disorders, including:
    • Hypoactive sexual desire disorder, defined as the persistent or recurrent deficiency of sexual fantasies, thought and/or desires for, or receptivity to, sexual activity, which causes personal distress.
    • Sexual aversion disorders, defined as the persistent or recurrent phobic aversion to and avoidance of sexual contact with a sexual partner, which causes personal distress.
  2. Sexual arousal disorders, defined as the persistent or recurrent inability to attain or maintain sufficient sexual excitement, causing personal distress. It may be expressed as lack of subjective excitement or a lack of genital (lubrication/swelling) or other somatic responses.
  3. Orgasmic disorder, defined as the persistent or recurrent difficulty, delay in or absence of attaining orgasm following sufficient sexual stimulation and arousal, which causes personal distress.
  4. Sexual pain disorders, including dyspareunia and vaginismus.
  5. Non-coital sexual pain disorder.

It is estimated that some 43 percent of American women experience female sexual dysfunction to some degree. Treatment options are limited. However, in 2000, a vacuum device, the Eros Clitoral Therapy Device, received clearance for marketing from the U.S. Food and Drug Administration (FDA) as a treatment of female sexual arousal and orgasmic disorders. The device is a handheld battery-operated vacuum device with a disposable cap placed over the clitoris. When activated, the vacuum device is designed to increase blood flow to the clitoris, causing the arteries to expand, thus putting pressure on the nerves that stimulate the clitoris. In addition, clitoral engorgement may activate an autonomic reflex that triggers arterial vasodilation, further resulting in a lubricating transudate.

Policy:
Vacuum therapy as a treatment of female sexual dysfunction is considered INVESTIGATIONAL.

Policy Guideline
The Eros Clitoral Therapy Device consists of a handheld battery-operated device plus a disposable cap. It is recommended that the disposable cap be replaced after every 10 uses. HCPCS code L7900 (vacuum erection system) has been used by some providers to code for the device, however, this code was modified for 2003 to state that it is for use for male vacuum erection devices only.

The only ICD-9 codes that specifically identify female sexual dysfunction are within the code range for mental disorders (302.7: Psychosexual dysfunction, code range). Other nonspecific ICD-9 codes that may have been used include the following:

625.5 Pelvic congestion syndrome
625.8 Other specified symptoms associated with female genital organs
625.9 Unspecified symptoms associated with female genital organs
627.4 States associated with artificial menopause
627.9 Unspecified menopausal and postmenopausal disorder
629.8 Other specified disorders of female genital organs
629.9 Unspecified disorder of female genital organs

Benefit Application:
BlueCard®/National Account Issues
Although the use of vacuum therapy is considered investigational, plans may also want to consider whether female sexual dysfunction is a medical condition and, if not, whether coverage of the Eros Clitoral Therapy Device may be adjudicated contractually, as opposed to based on the clinical data. In this regard, contractual/benefits language regarding non-organic male erectile dysfunction may establish a precedent
.

If coverage eligibility is not addressed contractually, some state or federal mandates (e.g., FEP) prohibit plans from denying FDA-approved technologies as investigational. In these instances, plans may have to consider the coverage eligibility of FDA-approved technologies on the basis of medical necessity alone.

Rationale:
Published data regarding vacuum therapy for female sexual dysfunction are limited. The Eros Clitoral Therapy Device received FDA clearance for marketing under a 510(k) process. As such, the device was not presented to an FDA advisory committee for review and discussion; therefore, the clinical data presented to the FDA are not publicly available. However, an FDA Talk Paper announcing approval of the device states that the data presented to the FDA consisted of 25 patients, 15 of whom had female sexual dysfunction and 10 who did not. (1) A literature search identified two published peer-reviewed articles. (2, 3) Both articles are authored by the same investigator using a similar study design and, thus, likely consist of overlapping patient populations. Therefore, the study with the largest number of patients is reviewed here. (2) A total of 32 patients participated in the clinical trial; 20 patients (nine premenopausal and 11 postmenopausal) reported female sexual dysfunction, while 12 patients (10 premenopausal and two postmenopausal) reported no sexual dysfunction. During the first three home uses of the device, patients were asked to note any change in sexual pleasure, including clitoral and labial engorgement, orgasm and vaginal lubrications. Each patient then completed a questionnaire, the Female Intervention Efficacy Index. With patients serving as their own control, 90 percent of the 20 patients with sexual dysfunction reported increased sensation; 80 percent reported increased lubrication; 45 percent reported an increased ability to achieve orgasm; and 80 percent reported increased sexual satisfaction. This uncontrolled trial of a small sample of self-selected patients of limited duration is not adequate to validate the long-term efficacy of vacuum therapy as a treatment of female sexual dysfunction.

References:

  1. FDA Talk Paper.
  2. Billups KL, Berman L, Berman J et al. A new non-pharmacological vacuum therapy for female sexual dysfunction. J Sex Marital Ther 2001; 27(5):435-41.
  3. Wilson SK, Delk JR, Billups KL. Treating symptoms of female sexual arousal disorder with the Eros-Clitoral Therapy Device. J Gend Specif Med 2001; 4(2):54-8.
  4. Billups KL. The role of mechanical devices in treating female sexual dysfunction and enhancing the female sexual response. World J Urol 2002; 20(2):137-41.
  5. Berman JR, Bassuk J. Physiology and pathophysiology of female sexual function and dysfunction. World J Urol 2002; 20(2):111-8.

Coding Section 

Codes Number Description
CPT    
ICD-9 Procedures      
ICD-9 Diagnosis   See Policy Guidelines  
HCPCS E1399 Durable medical Equipment, miscellaneous   
ICD-10 Diagnosis N94.89 Other specified conditions associated with female genital organs and menstrual cycle 
  R10.2 Pelvic and perineal pain
  N95.8 Other specified menopausal and perimenopausal disorders
  N95.9 Unspecified menopausal and perimenopausal disorder 
  N94.9 Unspecified condition associated with female genital organs and menstrual cycle 
Type of Service Durable medical Equipment  
Place of Service Outpatient  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

Index
Eros Clitoral Therapy Device
Female Sexual Dysfunction
Vacuum Therapy as a Treatment of Female Sexual Dysfunction

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

01/30/2019 

Annual review. No change to policy intent. 

01/29/2018 

Annual review. No change to policy intent. 

01/31/2017 

Annual review, no change to policy intent. 

01/14/2016 

Annual review, no change to policy intent. Added ICD-10 coding. 

01/21/2015 

Annual review, no change to policy intent. Added guidelines and coding. 

01/09/2014

Annual Review. No changes made.


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